Medtronic recalls Stealthstation Cranial Software versions 3.1.1-3.1.2 and 3.1.3 due to potential incorrect biopsy needle positioning during cranial procedures, risking tissue injury and additional surgery.
Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury.
Medtronic is recalling specific versions of its Stealthstation Cranial software because it can display incorrect biopsy needle positions during cranial procedures. This risk could lead to longer surgeries, additional procedures, or tissue damage. Affected users should contact Medtronic for details on the fix.
The software can become desynchronized during cranial biopsies, showing an incorrect needle position on the screen. This may cause the surgeon to proceed with the biopsy at a depth that could damage tissue or require additional surgery to correct the error.
Medical professionals using Medtronic Stealthstation Cranial software versions 3.1.1 through 3.1.3 for cranial biopsies are most at risk. Patients undergoing these procedures with the affected software versions may also be impacted.
Check if your software version is 3.1.1, 3.1.2, or 3.1.3 for Stealthstation Cranial or Synergy Cranial. Model numbers 9733763 (StealthStation Cranial) or 9735585 (Synergy Cranial) with the specified versions are affected.
Reach out to Medtronic directly to confirm your software version and get instructions for the fix.
Stealthstation Cranial Software versions 3.1.1, 3.1.2, and 3.1.3, and Synergy Cranial Software versions 3.1.1, 3.1.2, and 3.1.3.
The software can display an incorrect biopsy needle position during cranial procedures, potentially leading to tissue injury, longer surgery, or additional procedures.
No, but you should contact Medtronic to get the fix as soon as possible to avoid risks.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0383-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0383-2022 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
